U.S. patent application number 10/667521 was filed with the patent office on 2004-07-01 for apparatus and method for reducing fluid loss during a surgical procedure.
Invention is credited to Patterson, Frank, Trout, Hugh III.
Application Number | 20040127919 10/667521 |
Document ID | / |
Family ID | 32033611 |
Filed Date | 2004-07-01 |
United States Patent
Application |
20040127919 |
Kind Code |
A1 |
Trout, Hugh III ; et
al. |
July 1, 2004 |
Apparatus and method for reducing fluid loss during a surgical
procedure
Abstract
The present invention provides an occlusive system and method of
use at a surgical procedure. The occlusive system comprises a
fastener and an occlusive device in cooperation with the fastener.
An embodiment of the invention may further comprise a fastener tip
and a penetration apparatus. According to an embodiment of the
present invention, a method of reducing the loss of fluid at a
surgical site comprises the steps of: advancing an occlusive system
comprising a fastener having an occlusive device to the surgical
site; and deploying the surgical fastener having the occlusive
device at the surgical site.
Inventors: |
Trout, Hugh III; (Bethesda,
MD) ; Patterson, Frank; (Exeter, NH) |
Correspondence
Address: |
COLLIER SHANNON SCOTT, PLLC
3050 K STREET, NW
SUITE 400
WASHINGTON
DC
20007
US
|
Family ID: |
32033611 |
Appl. No.: |
10/667521 |
Filed: |
September 23, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60412549 |
Sep 23, 2002 |
|
|
|
60415778 |
Oct 4, 2002 |
|
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Current U.S.
Class: |
606/157 ;
606/200 |
Current CPC
Class: |
A61B 17/0057 20130101;
A61B 2017/00862 20130101; A61B 2017/00004 20130101; A61B 17/0644
20130101; A61B 2017/0647 20130101; A61B 17/064 20130101; A61B
2017/00654 20130101; A61B 17/0469 20130101; A61B 2017/00637
20130101; A61B 2017/00898 20130101; A61B 2017/0649 20130101 |
Class at
Publication: |
606/157 ;
606/200 |
International
Class: |
A61M 029/00 |
Claims
What is claimed is:
1. An occlusive system for use at a surgical site comprising: a
fastener; and an occlusive device in cooperation with the
fastener.
2. The system of claim 1, further comprising a fastener tip in
communication with the fastener.
3. The system of claim 1, further comprising a penetration
apparatus in communication with the fastener.
4. The system of claim 1, wherein the occlusive device comprises
one or more selected from the group consisting of a coil, band,
ribbon, valve, and flap.
5. The system of claim 1, wherein the occlusive device comprises at
least one coil.
6. The system of claim 1, wherein the occlusive device comprises at
least one band.
7. The system of claim 1, wherein the occlusive device comprises at
least one ribbon.
8. The system of claim 1, wherein the occlusive device comprises at
least one valve.
9. The system of claim 1, wherein the occlusive device comprises at
least one flap.
10. The system of claim 1, the occlusive device having a
substantially closed configuration.
11. The system of claim 1, the occlusive device having a first
substantially open configuration and a second substantially closed
configuration.
12. The system of claim 1, wherein the occlusive device collapses
into a substantially closed configuration.
13. The system of claim 1, wherein the occlusive device expands
into a substantially closed configuration.
14. The system of claim 1, wherein the occlusive device is disposed
within the fastener.
15. The system of claim 1, wherein the occlusive device is disposed
adjacent to the fastener.
16. An occlusive system for use at a surgical site comprising: a
fastener; a fastener tip in cooperation with the fastener; and an
occlusive device in cooperation with the fastener or the fastener
tip.
17. The system of claim 16, wherein the occlusive device is in
cooperation with the fastener.
18. The system of claim 16, wherein the occlusive device is in
cooperation with the fastener tip.
19. An occlusive system for use at a surgical site comprising: a
fastener; an occlusive device in cooperation with the fastener; and
a penetration apparatus in reversible communication with the
fastener and the occlusive device.
20. The system of claim 19, the occlusive device having a first
substantially open configuration and a second substantially closed
configuration.
21. An occlusive system for use at a surgical site comprising:
fastener means for fastening a first component to a second
component; and occlusive means in cooperation with the fastener
means for reducing fluid flow at the surgical site.
22. A method for reducing the loss of fluid at a surgical site
comprising the steps of: advancing an occlusive system comprising a
fastener having an occlusive device to a surgical site; and
deploying the surgical fastener having the occlusive device at the
surgical site.
23. The method of claim 22, further comprising the step of:
reducing the loss of fluid at the surgical site.
24. The method of claim 22, wherein the fluid is blood.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present invention relates to, and is entitled to the
benefit of the earlier filing date and priority of, application
Ser. No. 60/412,549, filed on Sep. 23, 2002, and application Ser.
No. 60/415,778, filed on Oct. 4, 2002.
FIELD OF THE INVENTION
[0002] The present invention relates to an apparatus and method for
reducing fluid loss during a surgical procedure. In particular, the
present invention relates to an apparatus and method for reducing
blood loss from a vessel during a surgical procedure.
BACKGROUND OF THE INVENTION
[0003] An aneurysm is a ballooning of the wall of an artery
resulting from the weakening of the artery due to disease or other
conditions. Left untreated, the aneurysm will frequently rupture,
resulting in loss of blood through the rupture and death.
[0004] Aortic aneurysms are the most common form of arterial
aneurysm and are life threatening. The aorta is the main artery
which supplies blood to the circulatory system. The aorta arises
from the left ventricle of the heart, passes upward and bends over
behind the heart, and passes down through the thorax and abdomen.
Among other arterial vessels branching off the aorta along its
path, the abdominal aorta supplies two side vessels to the kidneys,
the renal arteries. Below the level of the renal arteries, the
abdominal aorta continues to about the level of the fourth lumbar
vertebrae (or the navel), where it divides into the iliac arteries.
The iliac arteries, in turn, supply blood to the lower extremities
and perineal region.
[0005] It is common for an aortic aneurysm to occur in the portion
of the abdominal aorta between the renal arteries and the iliac
arteries. This portion of the abdominal aorta is particularly
susceptible to weakening, often resulting in an aortic aneurysm.
Such an aneurysm may be located near the iliac arteries. An aortic
aneurysm larger than about 5 cm in diameter in this section of the
aorta is ominous. Left untreated, the aneurysm may rupture,
resulting in rapid, and usually fatal, hemorrhaging. Typically, a
surgical procedure is not performed on aneurysms smaller than 5 cm
because it has not been established that surgical intervention is
beneficial for aneurysms that size.
[0006] Aneurysms in the abdominal aorta are associated with a
particularly high mortality rate; accordingly, current medical
standards call for urgent operative repair. Abdominal surgery,
however, results in substantial stress to the body. Although the
mortality rate for an aortic aneurysm is extremely high, there is
also considerable mortality and morbidity associated with open
surgical intervention to repair an aortic aneurysm. This
intervention involves penetrating the abdominal wall to the
location of the aneurysm to reinforce or replace the diseased
section of the aortic aneurysm. A prosthetic device, typically a
synthetic tube graft, is used for this purpose. The graft serves to
exclude the aneurysm from the circulatory system, thus relieving
pressure and stress on the weakened section of the aorta at the
aneurysm.
[0007] Repair of an aortic aneurysm is a major operative procedure.
Substantial morbidity accompanies the procedure, resulting in a
protracted recovery period. Further, the procedure entails a
substantial risk of mortality. While surgical intervention may be
indicated, the surgery carries attendant risks and certain patients
may not be able to tolerate the stress of intra-abdominal surgery.
It is, therefore, desirable to reduce the mortality and morbidity
associated with intra-abdominal surgical intervention.
[0008] In recent years, methods have been developed to attempt to
treat an aortic aneurysm without the attendant risks of
intra-abdominal surgical intervention. Among them are inventions
disclosed and claimed in Kornberg, U.S. Pat. No. 4,562,596 for
Aortic Graft, Device and Method for Performing an Intraluminal
Abdominal Aortic Aneurysm Repair; Lazarus, U.S. Pat. No. 4,787,899
for Intraluminal Graft Device, System and Method; and Taheri, U.S.
Pat. No. 5,042,707 for Intravascular Stapler, and Method of
Operating Same.
[0009] None of the known systems provide an apparatus that
selectively reduces blood loss from a vessel during attachment of a
surgical component, such as a prosthetic graft, to a vessel wall in
the manner of the embodiments of the present invention. In
particular, attachment devices, including, but not limited to
surgical fasteners, have been developed that are intended to attach
a surgical component to tissue, component to component, or tissue
to tissue. An example is the attachment of a prosthetic graft to an
aortic wall as described in U.S. Pat. Nos. 5,944,750 and 5,957,940,
which are hereby incorporated in their entirety by reference. When
the attachment device is inserted independently, or in conjunction
with a penetration apparatus, the attachment device will have an
opening through its center that could allow the exodus of blood
from within the aortic lumen unless some sort of occlusive
mechanism is built into the attachment device itself or into an
additional component used in conjunction with the attachment
device.
[0010] Therefore, it is an advantage of some, but not necessarily
all, embodiments of the present invention to provide a device that
may be added either to the attachment device or to an additional
component used in conjunction with the attachment device to reduce
blood loss during a surgical procedure.
[0011] Additional advantages of various embodiments of the
invention are set forth, in part, in the description that follows
for reducing blood loss from a vessel during a surgical
procedure.
SUMMARY OF THE INVENTION
[0012] Responsive to the foregoing challenges, Applicant has
developed an innovative apparatus and method for reducing blood
loss from a vessel during a surgical procedure at a surgical
site.
[0013] An alternative embodiment of the present invention is an
occlusive system for use at a surgical site comprising a fastener
and an occlusive device in cooperation with the fastener. The
system may further comprise a fastener tip in communication with
the fastener. The system may further comprise a penetration
apparatus in communication with the fastener. The occlusive device
may comprise one or more selected from the group consisting of a
coil, band, ribbon, valve, and flap. In an alternative embodiment,
the occlusive device may comprise at least one of a coil, band,
ribbon, valve, flap, or any other suitable element.
[0014] In an alternative embodiment, the occlusive device may have
a substantially closed configuration, or a first substantially open
configuration and a second substantially closed configuration. In
an alternative embodiment, the occlusive device may either collapse
or expand into a substantially closed configuration. In an
alternative embodiment, the occlusive device may be disposed within
the fastener, adjacent to the fastener, or have a first portion
disposed within the fastener and a second portion extending outside
the fastener.
[0015] An alternative embodiment of the present invention is an
occlusive system for use at a surgical site comprising a fastener,
a fastener tip in cooperation with the fastener, and an occlusive
device in cooperation with the fastener or the fastener tip. The
occlusive device may be in cooperation with the fastener, the
fastener tip, or both.
[0016] An alternative embodiment of the present invention is an
occlusive system for use at a surgical site comprising a fastener,
an occlusive device in cooperation with the fastener, and a
penetration apparatus in reversible communication with the fastener
and the occlusive device. The occlusive device may have a first
substantially open configuration and a second substantially closed
configuration.
[0017] An alternative embodiment of the present invention is an
occlusive system for use at a surgical site comprising fastener
means for fastening a first component to a second component, and
occlusive means in cooperation with the fastener means for reducing
fluid flow at the surgical site. The first component and second
component may be comprised of a surgical component, a tissue, or
both.
[0018] An alternative embodiment of the present invention is a
method for reducing the loss of fluid at a surgical site comprising
the steps of advancing an occlusive system comprising a fastener
having an occlusive device to a surgical site and deploying the
surgical fastener having the occlusive device at the surgical site.
The method may further comprise the step of reducing the loss of
fluid at the surgical site. The fluid may be blood, or any blood
component.
[0019] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory only, and are not restrictive of the invention as
claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] In order to assist the understanding of this invention,
reference will now be made to the appended drawings, in which like
reference characters refer to like elements.
[0021] FIG. 1A and B is a schematic view of an occlusive system in
accordance with an embodiment of the present invention.
[0022] FIG. 2A is a cut-away pictorial view of an occlusive system
including a penetration apparatus, fastener, occlusive device (not
shown), and a fastener tip according to an embodiment of the
present invention.
[0023] FIG. 2B is a perspective view of a fastener tip according to
an embodiment of the present invention.
[0024] FIG. 3 is a cut-away pictorial view of the insertion of the
penetration apparatus and the fastener through the surgical
component and the vessel wall in accordance with an embodiment of
the present invention.
[0025] FIG. 4 is a cut-away pictorial view of the fastener deployed
through the surgical component and the vessel in accordance with an
embodiment of the present invention.
[0026] FIGS. 5 and 6 are schematic views of an occlusive system
according to an embodiment of the present invention.
[0027] FIG. 7A and B is a schematic view of an occlusive system
according to an embodiment of the present invention.
[0028] FIG. 8A, B, C, D, E, and F is a perspective view of an
occlusive device according to an embodiment of the present
invention.
[0029] FIG. 9 is a cross-sectional view of an occlusive system
according to an embodiment of the present invention having an
opened flap valve.
[0030] FIG. 10 is a cross-sectional view of the embodiment of FIG.
9 with the flap valve in a closed configuration.
[0031] FIG. 11A and B is a schematic view of an example embodiment
of the device comprising a thin wall material.
[0032] FIG. 12A and B is a schematic view of another example
embodiment of the device comprising a thin wall material.
[0033] FIGS. 13, 14, and 15 are perspective views of further
example embodiments of the device directed to a valve.
[0034] FIG. 16A and B is a schematic view of an embodiment of the
device directed to the tapered tip.
[0035] FIG. 17A, B, and C is a schematic view of an embodiment of
the device directed to a thin wall material.
[0036] FIG. 18A, B, and C is a schematic view of an example
embodiment of the device directed to a polymeric cord.
[0037] FIGS. 19A and B and 20A, B, and C are schematic views of
further embodiments of the occlusive device directed to an
expandable material.
[0038] FIGS. 21 and 22 are cut-away pictorial views of further
embodiments of the occlusive device directed to a mass of shape
memory material in an opened and a closed configuration.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0039] Reference will now be made in detail to various embodiments
of the present invention, examples of which are illustrated in the
accompanying drawings. As shown in FIG. 1, occlusive system 10 in
accordance with an embodiment of the present invention comprises
occlusive device 50 in communication with surgical fastener 30.
Occlusive device 50 may be disposed within, or located adjacent to
surgical fastener 30. Occlusive device 50 may comprise, but is not
limited to, one or more coils, bands, ribbons, valves, flaps or any
other suitable occlusive member. Occlusive device 50 may be static,
expanding, and/or collapsing. In an alternative embodiment,
occlusive device 50 may remain in a first substantially closed
position, or may have a first substantially closed position and a
second substantially open position. In an embodiment having a first
and second position, occlusive device 50 is biased toward the first
substantially closed position.
[0040] In alternative embodiments, occlusive system 10 comprises
occlusive device 50 and surgical fastener 30 alone, or occlusive
device 50 and surgical fastener 30 in combination with surgical
fastener tip 40, and/or penetration apparatus 20, or any
combination of the above. Various embodiments are discussed in
greater detail in the following paragraphs.
[0041] In an alternative embodiment, occlusive system 10 comprises
occlusive device 50, surgical fastener 30, and surgical fastener
tip 40. Surgical fastener tip 40 is located adjacent to surgical
fastener 30. Occlusive device 50 may be disposed within and/or
located adjacent to fastener 30, or disposed within and/or located
adjacent to surgical fastener tip 40, as shown in FIG. 5.
[0042] In an alternative embodiment, occlusive system 10 may
comprise occlusive device 50, surgical fastener 30, and penetration
apparatus 20. Penetration apparatus 20 may comprise an optical
fiber or any other apparatus to penetrate the surgical site
including, but not limited to, a screw, a drill, a needle, or any
other suitable mechanical or thermal energy means. Various
embodiments of penetration apparatus 20 are described in U.S. Pat.
Nos. 5,972,023; 5,957,940; 6,371,919; 5,997,556; 6,248,118;
6,520,974; 6,607,555, all of which are incorporated in their
entirety by reference. When penetration apparatus 20 is used in
conjunction with occlusive system 10, occlusive device 50 is
maintained in the second substantially open position by the
presence of penetration apparatus 20. Upon withdrawal of
penetration apparatus 20 during the surgical procedure, occlusive
device 50 assumes its first substantially closed position thereby
reducing the loss of fluid at the surgical site. The fluid may be,
but is not limited to, blood, blood products, and blood components.
The surgical site may be within a lumen, such as, but not limited
to a vessel.
[0043] Occlusive system 10 in accordance with an alternative
embodiment of the present invention is described in connection with
FIGS. 2 through 4. In this embodiment, occlusive system 10
comprises fastener 30, occlusive device 50, tip 40, and penetration
apparatus 20. Occlusive system 10 reduces blood loss when fastener
30 spans a surgical site. At the surgical site, occlusive system 10
advances through a lumen, such as, but not limited to, a vessel
(not shown) that may have surgical component 100 adjacent to vessel
wall 200, as shown in FIG. 2. In an example embodiment illustrated
in FIG. 2, surgical component 100 and vessel wall 200 are shown
with inside or interluminal potion 200A and outside or adventitial
portion 200B. The surgical site, however, is not limited to a
surgical component and a vessel but may be any combination of the
surgical component and/or the vessel, such as, but not limited to,
a surgical component to a surgical component, a surgical component
to a vessel, or a vessel to a vessel.
[0044] In FIG. 2, fastener 30 is a flexible fastener that applies a
force to attach surgical component 100 to the vessel wall 200, as
disclosed in the following U.S. Patents and patent applications:
U.S. Provisional Patent Application No. 60/181,230, filed Feb. 9,
2000; U.S. patent application Ser. No. 09/442,768, filed Nov. 18,
1999; U.S. patent application Ser. No. 09/213,233, filed Dec. 17,
1998, now U.S. Pat. No. 5,997,556; U.S. patent application Ser. No.
08/958,524, filed Oct. 27, 1997, now U.S. Pat. No. 5,957,940; U.S.
patent application Ser. No. 08/896,415, filed Jul. 18, 1997, now
U.S. Pat. No. 5,944,750; and U.S. Provisional Patent Application
No. 60/051,209, filed Jun. 30, 1997. The subject matter of these
patents and patent applications is incorporated herein in its
entirety specifically by reference. In further example embodiments,
fastener 30 may or may not apply a compressive force to attach
surgical component 100 to vessel wall 200.
[0045] In an alternative embodiment shown in FIG. 2A, fastener 30
is disposed about or around penetration apparatus 20. Fastener 30
may be disposed about, around, proximal or distal to the surgical
site, or within penetration apparatus 20. In further example
embodiments, fastener 30 may be linked to penetration apparatus 20
in a manner such that the insertion of penetration apparatus 20 at
the surgical site also includes the insertion of fastener 30, as
illustrated in FIG. 3. Fastener 30 may be inserted at the surgical
site before, concurrently with, or after, penetration apparatus 20.
Fastener 30 may be sectioned into leading portion 32, middle
portion 34, and trailing portion 36. Each portion of fastener 30
may be similar or different in structure and may be composed of
similar or different materials such as, but not limited to,
plastic, metal, metal alloy, or any other suitable material.
[0046] In the embodiment illustrated in FIG. 2A, fastener 30 is
reversibly or irreversibly secured to tip 40. Tip 40 may facilitate
penetration of the surgical site and in further embodiments,
includes occlusive device 50 for reducing blood loss at the
surgical site, as shown in FIG. 5. In one embodiment, tip 40 is
attached to leading portion 32 of fastener 30, but also may be
located elsewhere on fastener 30, such as, but not limited to,
middle portion 34 and/or trailing portion 36. As shown in FIG. 2B,
tip 40 may include inner lumen 42, leading edge 44, middle portion
46, and trailing edge 48. Tip 40 may facilitate penetration with or
without the use of penetration apparatus 20, and may be composed of
any suitable material, such as, but not limited to, plastic, metal,
or metal alloy. Tip 40 shown in FIGS. 2A and 2B is of a conical or
a bell shape, but may be of any suitable shape.
[0047] In further alternative embodiments of occlusive system 10,
occlusive device 50 is housed within fastener 30 itself, located in
one or more of leading portion 32, middle portion 34, or trailing
portion 36, or into an apparatus attached to fastener 30, such as,
but not limited to, tip 40. When penetration apparatus 20 is
engaged with fastener 30 as depicted in FIG. 2A, occlusive device
50 assumes a second substantially open configuration. When
penetration apparatus 20 is removed as shown in FIG. 4, occlusive
device 50 assumes its first substantially closed configuration.
[0048] Various alternative embodiments of occlusive device 50 of
occlusive system 10 will now be described with reference to FIGS. 1
and 6 through 22. In example embodiments illustrated in FIG. 1,
occlusive device 50 comprises a spring winding or coil member that
may be tapered and attached to fastener 30 and/or tip 40. Occlusive
device 50 may be attached to fastener 30 in various ways such as,
but not limited to, extension of the fastener wires, welded,
threaded over the fastener, or any other suitable method of
attachment. When penetration apparatus 20 is engaged with fastener
30 in FIG. 1A, occlusive device 50 is in a second substantially
open configuration. When penetration apparatus 20 is removed,
occlusive device 50 retracts toward fastener 30 into a first
substantially closed configuration, as shown in FIG. 1 B. This
retraction of occlusive device 50 assists in the reduction of fluid
loss during and following the surgical procedure. Various
embodiments of occlusive device 50 may be disposed at leading
portion 32, middle portion 34, or trailing portion 36 of fastener
30 and/or with an apparatus, such as, but not limited to, tip 40.
Illustrated in FIGS. 5 and 6, occlusive device 50 is located within
tip 40.
[0049] An alternative embodiment illustrated in FIGS. 7A and 7B
shows occlusive device 50 disposed in trailing portion 36 of
fastener 30. In particular, occlusive device 50 is comprised of a
spring or spiral coil which may be fabricated from a solid disk. In
FIGS. 7A and 7B, fastener 30 is also attached to tip 40 opposite
occlusive device 50. When fastener 30 encompasses penetration
apparatus 20, as in FIG. 7A, occlusive device 50 assumes a second
substantially open configuration. When penetration apparatus 20 is
withdrawn, as shown in FIG. 7B, occlusive device 50 assumes its
first substantially closed configuration or retracted shape and
provides resistance to fluid and/or blood flow. Occlusive device
50, according to this embodiment, may be fabricated from a metal, a
polymeric material or any other suitable material and may be
attached to fastener 30 in a number of ways, including, but not
limited to, material specific welding, or any other suitable
bonding techniques.
[0050] The alternative embodiments of occlusive device 50 shown in
FIGS. 8A and 8B comprise a solid tapering cylinder with flap
segments 52 that may be cut in a longitudinal manner and biased in
a first substantially closed position. When penetration apparatus
20 is inserted through occlusive device 50, flap segments 52 may be
distracted into a second substantially open position and when
penetration apparatus 20 is withdrawn from occlusive device 50,
flap segments 52 return to their first substantially closed
position. In additional embodiments, occlusive device 50 is
disposed within or attached to fastener 30 or into another
structure such as, but not limited to, tip 40. FIGS. 8B through 8F
depict further, non-limiting embodiments of occlusive device 50
with sagittal cuts there through. In particular, FIG. 8B is a
straight cone; FIG. 8C is an insloping cone; FIG. 8D is an
outsloping cone; FIG. 8E is a hemisphere; and FIG. 8F is an
abbreviated hourglass.
[0051] In the alternative embodiments of the present invention
depicted in FIGS. 9 and 10, occlusive device 50 comprises a flap
valve from a sagittal cut through tip 40 that may be attached to
leading portion 32 of fastener 30. In FIG. 9, penetration apparatus
20 distracts occlusive device 50 such as those depicted in FIGS. 8A
through 8F. In FIG. 10, penetration apparatus 20 is removed
allowing occlusive device 50 to return to its first substantially
closed position within tip 40.
[0052] Another alternative embodiment of occlusive device 50 is
shown in FIGS. 11 and 12. Occlusive device 50 comprises a thin wall
material attached to tip 40, leading portion 32, middle portion 34,
and/or trailing portion 36 of fastener 30 or at any other suitable
location. The thin wall material of occlusive device 50 may
comprise a thin wall tube, polymeric, biodegradable polymer or any
other suitable material. In FIGS. 11A and 11B, occlusive device 50
may be preformed over trailing portion 36 of fastener 30. In FIG.
11A, a portion of penetration apparatus 20 is disposed within
fastener 30 such that occlusive device 50 encircles penetration
apparatus 20. In FIG. 11B, penetration apparatus 20 is withdrawn
and occlusive device 50 collapses into its first substantially
closed position assisting in the reduction of fluid and/or blood
flow through fastener 30.
[0053] In a further alternative embodiment, occlusive device 50
illustrated in FIGS. 12A and 12B attaches to tip 40. The thin wall
material comprising occlusive device 50 is preformed over trailing
edge 48 of tip 40. Similarly, the thin wall material may be
composed of thin wall tube, polymeric, biodegradable or any other
suitable material. In FIG. 12A, penetration apparatus 20 extends
through fastener 30 and is encircled by occlusive device 50. In
FIG. 12B, the removal of penetration apparatus 20 collapses
occlusive device 50 into its first substantially closed
configuration resembling a "duck-bill" thereby reducing fluid
and/or blood flow through fastener 30.
[0054] In FIGS. 13 through 15, additional alternative embodiments
directed to occlusive device 50 are shown. In these figures,
occlusive device 50 comprises a valve. Occlusive device 50 may be
located within fastener 30 or within a separate apparatus to be
attached to fastener 30, such as, but not limited to, tip 40.
Occlusive device 50 may be constructed of metal alloys, synthetic
material with or without elastomeric properties, or any other
suitable materials. Occlusive device 50 of FIG. 13 is in a
"duck-bill" configuration. In FIG. 14, occlusive device 50 is a
tricuspid valve configuration having at least one cusp.
Alternatively, in FIG. 15, occlusive device 50 is a radially
expansive aperture valve. When penetration apparatus 20 inserts
through occlusive device 50 illustrated in FIGS. 13 through 15,
occlusive device 50 distracts or opens and when penetration
apparatus 20 is removed, occlusive device 50 assumes its first
substantially closed configuration. Occlusive device 50 depicted in
FIGS. 13 through 15 is illustrated in the first substantially
closed configuration.
[0055] A further alternative embodiment of occlusive device 50 is
illustrated in FIGS. 16A and 16B. Occlusive device 50 is integrated
with tip 40 to form a unitary structure. In FIGS. 16A and 16B,
occlusive device 50 comprises a circular cone having multiple webs
that may be equispaced and/or identical. The embodiment of FIGS.
16A and 16B depicts tip 40 shaped in a cone having three webs. In
alternative embodiments, tip 40 is threaded, crimped, shrunk or
associated with leading portion 32 of fastener 30 or via any other
suitable means. In FIG. 16A, penetration apparatus 20 is positioned
within fastener 30 and distends occlusive device 50 of tip 40. As
shown in FIG. 16B, penetration apparatus 20 is withdrawn resulting
in a collapse of occlusive device 50 to its first substantially
closed position to reduce fluid and/or blood flow through the
fastener 30.
[0056] According to another alternative embodiment illustrated in
FIGS. 17A and 17B, occlusive device 50 is comprised of a thin wall
material that may be shrunk over leading portion 32 or trailing
portion 36 of fastener 30. Occlusive device 50 may be secured to
fastener 30 by crimping, screwing, shrink-wrapping, heating,
welding, or attachment by any other suitable means. In example
embodiments depicted in FIG. 17A, occlusive device 50 may be
polymeric tubing shrunk over leading portion 32 of fastener 30.
Illustrated in FIG. 17B, the cross section shows occlusive device
50 in a second substantially open configuration with penetration
apparatus 20 in position within fastener 30. FIG. 17C depicts
occlusive device 50 in its first substantially closed configuration
after removal of penetration apparatus 20 from the surgical
site.
[0057] Further alternative embodiments of the invention are shown
in FIGS. 18A and 18B. Occlusive device 50 may comprise a polymeric
coil, ribbon, or cord positioned intermittently between and among a
plurality of coils of fastener 30. Illustrated in FIG. 18A,
occlusive device 50 is disposed in middle portion 34 of fastener 30
and around penetration apparatus 20, although occlusive device 50
may be disposed in leading portion 32 or trailing portion 36 of
fastener 30. In FIG. 18B, separation 56 of occlusive device 50 is
shown with fastener 30 and penetration apparatus 20. Occlusive
device 50 is also in a second substantially open configuration in
the presence of penetration apparatus 20. In contrast, FIG. 18C
illustrates occlusive device 50 in its first substantially closed
configuration with removal of penetration apparatus 20.
[0058] Various alternative embodiments of the present invention are
also illustrated in FIGS. 19A and 19B. Occlusive device 50 may
comprise one or more expandable members comprised of a polymeric
foam or elastomer, or any other suitable expandable component. In
an alternative embodiment, occlusive device 50 is located in tip 40
where it is compressed in the presence of penetration apparatus 20
into its second substantially open position, as shown in FIG. 19A.
When penetration apparatus 20 is removed, as shown in FIG. 19B,
occlusive device 50 may assume its first substantially closed
position within tip 40 thereby reducing fluid and/or blood flow
through fastener 30.
[0059] In other alternative embodiments, tip 40 may be composed of
expandable material or biodegradable material (not shown). In this
instance, fastener 30 is aligned over penetration apparatus 20 and
over a reduced diameter of tip 40. With the removal of penetration
apparatus 20, tip 40 may enlarge thereby forming a barrier to
reduce the flow of fluid and/or blood through fastener 30.
[0060] As illustrated in FIGS. 20A, 20B and 20C, the expandable
material of occlusive device 50 comprises an expandable plug. In
various embodiments, occlusive device 50 is comprised of a
polymeric or electrometric foam or any other suitable expandable
component. Occlusive device 50, as illustrated in FIG. 20A and 20B,
is positioned in a slot within tip 40. Tip 40 may be attached to
fastener 30. With penetration apparatus 20 in place, as shown in
FIG. 20B, occlusive device 50 is compressed and held in its second
substantially open position. With the removal of penetration
apparatus 20 from the surgical site, as depicted in FIG. 20C,
occlusive device 50 may expand to its first substantially closed
position, thereby assisting in the reduction of fluid and/or blood
flow through fastener 30.
[0061] Example alternative embodiments illustrated in FIGS. 21 and
22 are directed to occlusive device 50 comprising a mass of shaped
memory material. Occlusive device 50 may be comprised of coils,
ribbon, and/or wire or any other suitable material disposed within
tip 40 or any other appropriate location within tip 40 or fastener
30. In FIG. 21, occlusive device 50 is in a deformed second
substantially open configuration allowing penetration apparatus 20
to pass through fastener 30. In FIG. 22 with the removal of
penetration apparatus 20 from the surgical site, occlusive device
50 assumes its first substantially closed or pre-formed
configuration thereby inhibiting the flow of fluid and/or blood
through fastener 30. Occlusive device 50 may also possess thrombic
properties to inhibit the blood flow. Occlusive device 50 may
assume a configuration of such a size that it would not be able to
move through fastener 30 or tip 40.
[0062] An embodiment of the method of operating occlusive system 10
will now be described. Occlusive system 10 comprising fastener 30
and occlusive device 50 is advanced to a surgical site through a
lumen, such as, but not limited to, a vessel as disclosed in the
following U.S. Patents and patent applications: U.S. Provisional
Patent Application No. 60/181,230, filed Feb. 9, 2000; U.S. patent
application Ser. No. 09/442,768, filed Nov. 18, 1999; U.S. patent
application Ser. No. 09/213,233, filed Dec. 17, 1998, now U.S. Pat.
No. 5,997,556; U.S. patent application Ser. No. 08/958,524, filed
Oct. 27, 1997, now U.S. Pat. No. 5,957,940; U.S. patent application
Ser. No. 08/896,415, filed Jul. 18, 1997, now U.S. Pat. No.
5,944,750; and U.S. Provisional Patent Application No. 60/051,209,
filed Jun. 30, 1997, incorporated in their entirety specifically by
reference. Occlusive system 10 is deployed at the surgical site
attaching surgical component 100 to vessel wall 200, or surgical
component to surgical component, or vessel to vessel, or any
combination of the above. Occlusive device 50 in its first
substantially closed position reduces blood loss through fastener
30 during and following the surgical procedure.
[0063] In an alternative embodiment shown in FIG. 2A, occlusive
system 10 is advanced to the surgical site through a lumen, such
as, but not limited to, a vessel (not shown). Penetration apparatus
20 is advanced either simultaneously or in sequence with tip 40 of
fastener 30 to contact surgical component 100. Penetration
apparatus 20 positioned with fastener 30 engages occlusive device
50 resulting in a second substantially open configuration.
Penetration apparatus 20 and/or tip 40 creates an aperture within
surgical component 100 and vessel wall 200. As indicated in FIG. 3,
penetration apparatus 20 extends through surgical component 100 and
vessel wall 200 such that fastener 30 also extends through surgical
component 100 and vessel wall 200. In FIG. 4, penetration apparatus
20 is withdrawn from within fastener 30. Leading portion 32 of
fastener 30 attached to tip 40 and trailing portion 36 resume their
preformed coiled coil shape while middle portion 34 extends through
surgical component 100 and vessel wall 200. With the withdrawal of
penetration apparatus 20, occlusive device 50 assumes its first
substantially closed configuration thereby reducing the flow of
blood from adventitial portion 200B to luminal portion 200A and/or
vice versa (not shown). Occlusive system 10 may be deployed at the
surgical site as described in U.S. Pat. Nos. 5,972,023; 5,957,940;
6,371,919; 5,997,556; 6,248,118; 6,520,974; 6,607,555, and U.S.
patent application Ser. No. 10/417,163, filed Apr. 17, 2003, herein
incorporated in their entirety by reference. Occlusive system 10
may be advanced to the surgical site and deployed without the use
of a penetration apparatus 20, or without the use of a surgical tip
40. Various embodiments of occlusive system 10 may be used to
attach one or more of a surgical component, such as, but not
limited to a prosthetic graft, and a tissue, such as, but not
limited to a vessel. In one example embodiment occlusive system 10
comprising occlusive device 50 and surgical fastener 30 is deployed
during the surgical procedure to attach a surgical component to a
vessel, a surgical component to another surgical component, a
vessel to vessel, or any combination thereof.
[0064] Numerous characteristics and advantages have been set forth
in the foregoing description, together with details of structure
and function. The novel features are pointed out in the appended
claims. The disclosure, however, is illustrative only, and changes
may be made in detail, especially in matters of shape, size and
arrangement of parts, within the principle of the invention, to the
full extent indicated by the broad general meaning of the terms in
which the appended claims are expressed.
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